Should genetic testing be banned at home?
Most recently, the U.S. Food and Drug Administration (FDA) banned 23andMe from selling genetic tests for home use. The agency's medical experts claim that the manufacturer failed to provide evidence of its claim that tests worth $ 99 can help its customers make informed decisions on issues related to their health, despite the fact that this evidence has been requested for more than five years. 23andMe claims that in 2013, more than 200,000 people used the test offered by the company.
The company's website says that by analyzing the DNA contained in the client's saliva sample, "23andMe will help you learn more about your health and you will be able to take an active part in taking care of it." However, the FDA claims that making important decisions based on the results of such testing can be life-threatening.
A long-time opponent of the use of genetic tests like the proposed 23andMe, director of the Center for Pharmacogenomics and the Study of Complex Diseases at Rutgers University Scott Diehl is confident that the FDA has made the right decision. In this regard, the correspondent of Rutgers Today asked him a number of questions.
Rutgers Today: What's wrong with allowing people to buy a product that lets them know more about their DNA than they previously knew?
Dil: The picture that people get as a result of such testing is so incomplete that it makes it useless. For several years, 23andMe has been informing uninitiated clients that their risk of developing very complex diseases, such as diabetes mellitus, rheumatoid arthritis, gluten enteropathy, heart disease, stroke and schizophrenia, is higher or lower than the average level based on one or two inherited genetic variations.
Most geneticists are convinced that the risk of developing these diseases is determined by thousands of genetic variations. The use of such genetic tests can be compared to an attempt to predict the breakdown of a car during a long journey based on the results of checking a pair of bolts or one of the wheels.
Rutgers Today: Even if the information is so scarce, what harm can it do?
Dil: Such defective tests for complex diseases can mislead people. Based on the test results, a person can assess their risk as lower or higher than it actually is. As a result, he may not pay due attention to such important preventive measures as, for example, maintaining body weight, optimizing diet and physical activity based on false data about the low risk of developing diseases such as diabetes mellitus or diseases of the cardiovascular system.
Rutgers Today: What do you say about testing for specific life-threatening diseases?
Dil: Tests that predict a person's risk of developing fatal diseases, such as breast cancer or serious side effects from taking medications, should not be directly available to consumers. The use of such tests requires the appointment and interpretation of medical specialists and specially trained genetic consultants, because decisions made on the basis of the results obtained can have serious health consequences, as well as have a psychological effect on both the patient and his family members. Few people who do not have a medical education have enough knowledge to understand what the results actually mean. Due to inferiority, the results of such testing may unreasonably cause panic in some and at the same time reassure other people who, because of this false confidence, will not consult a doctor in a timely manner and will not pass more detailed testing offered by specialized medical and genetic laboratories.
Rutgers Today: Can further improvements in testing technology, as well as new genetic information or additional precautions change your attitude to genetic testing at home?
Dil: Despite the fact that the cost of DNA analysis kits is rapidly decreasing, the difficulties with interpreting the huge amount of incoming data go far beyond financial costs. Testing for diseases with serious health consequences should be carried out under strict control. Today, dozens of companies aggressively offer tests for various diseases on the market that have not passed clinical confirmation. The public should be interested in the fact that the FDA ensures control over this growing industry in such a way that consumers do not pay for useless information and that the test results are convincingly confirmed by the results of clinical trials, just as the procedure for authorizing the clinical use of medicines and medical equipment requires.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of Rutgers University:
Hot Topic: Putting the Brakes on Home Genetic Testing.
09.12.2013